1. Cochrane Database Syst Rev. 2016 Jul 5;7:CD003839. doi:
10.1002/14651858.CD003839.pub3.

Self-monitoring and self-management of oral anticoagulation.

Heneghan CJ(1), Garcia-Alamino JM, Spencer EA, Ward AM, Perera R, Bankhead C,
Alonso-Coello P, Fitzmaurice D, Mahtani KR, Onakpoya IJ.

Author information: 
(1)Nuffield Department of Primary Care Health Sciences, University of Oxford, New
Radcliffe House, Radcliffe Observatory Quarter, Oxford, Oxfordshire, UK, OX2 6GG.

Comment in
    Evid Based Nurs. 2017 Jan;20(1):17.

Update of
    Cochrane Database Syst Rev. 2010;(4):CD003839.

BACKGROUND: The introduction of point-of-care devices for the management of
patients on oral anticoagulation allows self-testing by the patient at home.
Patients who self-test can either adjust their medication according to a
pre-determined dose-INR (international normalized ratio) schedule
(self-management), or they can call a clinic to be told the appropriate dose
adjustment (self-monitoring). Increasing evidence suggests self-testing of oral
anticoagulant therapy is equal to or better than standard monitoring. This is an 
updated version of the original review published in 2010.
OBJECTIVES: To evaluate the effects on thrombotic events, major haemorrhages, and
all-cause mortality of self-monitoring or self-management of oral anticoagulant
therapy compared to standard monitoring.
SEARCH METHODS: For this review update, we re-ran the searches of the Cochrane
Central Register of Controlled Trials (CENTRAL), 2015, Issue 6, the Cochrane
Library, MEDLINE (Ovid, 1946 to June week 4 2015), Embase (Ovid, 1980 to 2015
week 27) on 1 July 2015. We checked bibliographies and contacted manufacturers
and authors of relevant studies. We did not apply any language restrictions .
SELECTION CRITERIA: Outcomes analysed were thromboembolic events, mortality,
major haemorrhage, minor haemorrhage, tests in therapeutic range, frequency of
testing, and feasibility of self-monitoring and self-management.
DATA COLLECTION AND ANALYSIS: Review authors independently extracted data and we 
used a fixed-effect model with the Mantzel-Haenzel method to calculate the pooled
risk ratio (RR) and Peto's method to verify the results for uncommon outcomes. We
examined heterogeneity amongst studies with the Chi(2) and I(2) statistics and
used GRADE methodology to assess the quality of evidence.
MAIN RESULTS: We identified 28 randomised trials including 8950 participants
(newly incorporated in this update: 10 trials including 4227 participants). The
overall quality of the evidence was generally low to moderate. Pooled estimates
showed a reduction in thromboembolic events (RR 0.58, 95% CI 0.45 to 0.75;
participants = 7594; studies = 18; moderate quality of evidence). Both, trials of
self-management or self-monitoring showed reductions in thromboembolic events (RR
0.47, 95% CI 0.31 to 0.70; participants = 3497; studies = 11) and (RR 0.69, 95%
CI 0.49 to 0.97; participants = 4097; studies = 7), respectively; the quality of 
evidence for both interventions was moderate. No reduction in all-cause mortality
was found (RR 0.85, 95% CI 0.71 to 1.01; participants = 6358; studies = 11;
moderate quality of evidence). While self-management caused a reduction in
all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84; participants = 3058; studies =
8); self-monitoring did not (RR 0.94, 95% CI 0.78 to 1.15; participants = 3300;
studies = 3); the quality of evidence for both interventions was moderate. In 20 
trials (8018 participants) self-monitoring or self-management did not reduce
major haemorrhage (RR 0.95, 95% CI, 0.80 to 1.12; moderate quality of evidence). 
There was no significant difference found for minor haemorrhage (RR 0.97, 95% CI 
0.67 to 1.41; participants = 5365; studies = 13). The quality of evidence was
graded as low because of serious risk of bias and substantial heterogeneity (I(2)
= 82%).
AUTHORS' CONCLUSIONS: Participants who self-monitor or self-manage can improve
the quality of their oral anticoagulation therapy. Thromboembolic events were
reduced, for both those self-monitoring or self-managing oral anticoagulation
therapy. A reduction in all-cause mortality was observed in trials of
self-management but not in self-monitoring, with no effects on major haemorrhage.

DOI: 10.1002/14651858.CD003839.pub3 
PMID: 27378324  [Indexed for MEDLINE]